MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT TI L/P 6 CF INT WOSP ATT SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8716001

Device Problems No Display/Image (1183); Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4: (expiry date: 11/2024).H11: section a through f:the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that sometime post a port placement, the ct mark allegedly failed to display under x-ray imaging.There was no reported patient injury.

Event Description

It was reported that sometime post a port placement, the ct mark allegedly failed to display under x-ray imaging.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.Three chest x-rays were provided for review.It depict the device placed via a right jugular access.The port has a triangular radiopaque housing, three open suture ports and does not have a ct marker.Therefore the investigation is confirmed for the reported poor quality image issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 11/2024), g3, h6 (method) h11: h6 (device, result, conclusion) h11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

• Brand Name: POWERPORT TI L/P 6 CF INT WOSP ATT SL
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18518783
• MDR Text Key: 333539214
• Report Number: 3006260740-2023-06139
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098949
• UDI-Public: (01)00801741098949
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K072549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8716001
• Device Lot Number: REHR1057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1